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A.) Glucose Shepherd Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.

The Glucose Shepherd Blood Glucose Monitoring System consists of the Glucose Shepherd Blood Glucose meter and the Glucose Shepherd Blood Glucose test strips. The Glucose Shepherd Blood Glucose meter is used only with Glucose Shepherd Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh.

The Glucose Shepherd Control Solutions are for use with the Glucose Shepherd Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

B.) Glucose Shepherd Pro Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Pro Blood Glucose Monitoring System may be used for multiple patients in a professional healthcare setting. I is intended for use as an aid in monitoring the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing devices. It should not be used for the diagnosis or screening of diabetes, for the testing of neonates, or for testing of arterial blood.

The Glucose Shepherd Pro Blood Glucose Monitoring System consists of the Glucose Shepherd Pro Blood Glucose meter and the Glucose Shepherd Pro Blood Glucose test strips. The Glucose Shepherd Pro Blood Glucose meter is used only with Glucose Shepherd Pro Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh.

The Glucose Shepherd Pro control solutions are for use with the Glucose Shepherd Pro Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

A.) Glucose Shepherd Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions(Level 1, 2 and 3), lancing device, and commercially available sterilized lancets. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose presented in the sample, providing a quantitative measure of glucose level in whole blood.

B.) Glucose Shepherd Pro Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions(Level 1, 2 and 3) and single-use lancing devices. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose level presented in the sample, providing a quantitative measure of glucose level in whole blood.

This 510(k) summary provides limited information regarding the performance studies. Therefore, a comprehensive description of acceptance criteria and the entire study that proves the device meets those criteria cannot be fully extracted.

However, based on the provided text, here's what can be gathered and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that both the Glucose Shepherd Blood Glucose Monitoring System and the Glucose Shepherd Pro Blood Glucose Monitoring System were studied in laboratory and clinical settings, and these studies "have demonstrated that this system meets the performance requirements of its intended use."

While explicit numerical acceptance criteria are not detailed in this summary, in the context of blood glucose monitoring systems, "performance requirements" typically refer to accuracy standards. For example, ISO 15197 (In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus) is a commonly referenced standard. A key part of this standard's accuracy requirement is that a certain percentage of results (e.g., 95%) must fall within a defined range of a reference method (e.g., within ±15 mg/dL for glucose concentrations <100 mg/dL and within ±15% for glucose concentrations ≥100 mg/dL).

Given the submission is for a 510(k), the device must demonstrate substantial equivalence to a predicate device. This implies that its performance (including accuracy) is at least as good as, if not better than, the predicate. Therefore, the "reported device performance" is essentially that the device meets relevant accuracy standards and is substantially equivalent to the predicate device.

Since no specific numerical acceptance criteria or detailed performance data are provided in the summary, we can only state the general claim.

2. Sample Size Used for the Test Set and the Data Provenance

The document mentions "clinical settings" and "clinical testing results" but does not specify:

• The exact sample size for the test set.
• The country of origin of the data.
• Whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the 510(k) summary. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer) rather than reliance on human expert consensus, so the concept of "experts establishing ground truth" as it applies to image-based diagnostic systems might not be directly applicable here.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Adjudication methods (like 2+1, 3+1) are typically relevant for studies where human interpretation of data is being assessed, often in imaging or subjective diagnostic tasks. For objective measurements like blood glucose, adjudication would refer to how discrepancies between the device and the reference method or across multiple device measurements were handled, which is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done.
• This type of study is not relevant for a blood glucose monitoring system, which is a quantitative measurement device rather than an AI-driven image interpretation or diagnostic system that assists human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• A standalone performance study was done.
• The entire premise of a blood glucose monitoring system is its standalone performance (the meter and test strip system providing a direct quantitative measurement). The document states, "The performance... was studied in the laboratory and in clinical settings. The studies have demonstrated that this system meets the performance requirements of its intended use." This confirms a standalone performance evaluation.

7. The Type of Ground Truth Used

• The ground truth for blood glucose monitoring systems is typically established by a highly accurate laboratory reference method, such as a YSI glucose analyzer. While not explicitly stated in the summary, this is the standard practice for evaluating such devices. The document refers to "laboratory testing results" which would involve comparison against such a reference.

8. The Sample Size for the Training Set

• This information is not provided in the 510(k) summary. For a blood glucose monitoring system based on an amperometric method, the "training set" concept (as used in machine learning) is generally not directly applicable. The device's calibration and algorithm are developed through engineering and chemical principles, then validated through testing. If the question refers to the samples used to establish the initial calibration curve or internal algorithms, that detail is not disclosed.

9. How the Ground Truth for the Training Set was Established

• As mentioned in point 8, the concept of a "training set" for ground truth (in the machine learning sense) is not directly applicable to this type of device. The accuracy of the device's measurement is established through rigorous internal development and external validation against highly precise laboratory reference instruments, which would serve as the "ground truth" for evaluating the system's accuracy. These reference instruments are themselves calibrated and maintained according to strict laboratory standards.

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